The Effectiveness and Safety in the Treatment of Circumferential Pulmonary Vein Isolation (CPVI) for Symptomatic Paroxysmal Atrial Fibrillation With THERMOCOOL® SMARTTOUCH™ Catheter in China, A Multi-center Clinical Registry Study

Biosense Webster, Inc.0 sites200 target enrollmentJuly 1, 2015

ConditionsAtrial Fibrillation

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: Biosense Webster, Inc.
Enrollment: 200
Primary Endpoint: Percentage of Patients With Freedom From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This is a prospective effectiveness and safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation.

Detailed Description

The purpose of this study is to assess the effectiveness and safety of the THERMOCOOL® SMARTTOUCH™ catheter in the treatment of drug refractory symptomatic paroxysmal atrial fibrillation (PAF) undergoing CPVI.

Registry

clinicaltrials.gov

Start Date

July 1, 2015

End Date

June 30, 2017

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Biosense Webster, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18 years or older
•Failure of at least one antiarrhythmic drug (AAD) for AF (class I or III, or AV nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic AF, or intolerance to the AAD
•Patients with paroxysmal AF eligible for catheter ablation
•Patients with symptomatic PAF who have had at least one documented AF episode in the twelve (12) months prior to enrollment. Documentation may include but is not limited to electrocardiogram (ECG), Holter monitor (HM) or transtelephonic monitor (TTM)
•Able and willing to comply with all pre-, post- and follow-up testing and requirements
•Be able to sign IRB/EC-approved informed consent form

Exclusion Criteria

•AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
•Previous surgical or catheter ablation for AF
•Any PCI, cardiac surgery, or valvular cardiac surgical or percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repart or replacement and presence of a prosthetic valve) within the past 2 months.
•Any carotid stenting or endarterectomy.
•Coronary artery bypass graft (CABG) procedure within the last 180 days (6 months)
•AF episodes lasting longer than 7 days or terminated via cardioversion
•Documented left atrial thrombus on imaging
•Uncontrolled heart Failure or New York Heart Association (NYHA) class III or IV
•Myocardial Infarction within the previous 60 days (2 months)
•Documented thromboembolic event (including TIA) within the past 12 months

Outcomes

Primary Outcomes

Percentage of Patients With Freedom From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes

Time Frame: 12 Months

The primary effectiveness endpoint for this study is freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up after the index ablation procedure (includes a three-month blanking period).

Secondary Outcomes

Percentage of Patients Where Acute Success Was Achieved(0.5 hours)
Average Contact Force Per Pulmonary Vein Ablation Procedure(1 day during procedure)
Percent of Subjects With Pulmonary Vein Reconnection for the Index Procedure(1 day during procedure)
Procedure Time, Ablation Time and Fluoroscopy Time(1 day during procedure)